ISO 23190:2021

Overview

ISO 23190:2021 specifies a standardized HPLC (high-performance liquid chromatography) method for the qualitative and semi-quantitative determination of aristolochic acid I in natural products used in Traditional Chinese Medicine (TCM). The standard provides sample preparation procedures, chromatographic conditions, system suitability criteria and guidance on method validation and result evaluation to help laboratories detect this nephrotoxic and carcinogenic compound.

Key topics and technical requirements

• Scope: Detection of aristolochic acid I in raw herbal materials and manufactured herbal products using HPLC-DAD.
• Principle: HPLC with a quaternary pump, degasser, autosampler, column compartment and diode array detector (DAD); UV detection at 254 nm.
• Column and mobile phases: Stationary phase - octadecylsilyl bonded silica (C18) or equivalent; mobile phase A - acetonitrile; mobile phase B - 0.05% phosphoric acid. (See Annex A for typical chromatographic conditions.)
• Standards and reagents: Stock standard prepared by dissolving 2 mg aristolochic acid I in methanol (store at 4 °C); working standard ~0.25 µg/ml. Use chromatographic-grade solvents and high-purity water.
• Sample preparation: Two test solutions are described:
  • Test solution I for raw herbal material: 0.5 g powder extracted with 70–80% methanol, ultrasonication 40 min, filtration (0.45 µm).
  • Test solution II for extracts/solid formulations: equivalent extraction, evaporation and reconstitution to a defined concentration (20 mg raw material per ml), filtration.
• Procedure and acceptance criteria: Inject 10–20 µl of standard and test solutions; compare retention time and UV spectra. Relative standard deviation of retention time ≤ 5.0%. Recovery of sample/blank between 70% and 125% for reliable results.
• Confirmation & validation: Recommend LC‑MS (Annex B) to validate positive findings. Method validation should address LOD, repeatability, sensitivity, stability and RSD.

Applications and users

ISO 23190:2021 is intended for:

• Quality control laboratories in TCM and herbal-product manufacturing
• Regulatory and public‑health agencies performing safety surveillance
• Pharmacopoeial bodies and conformity assessment laboratories
• Research groups studying herbal safety and contamination

Practical uses include screening raw materials and finished herbal products for aristolochic acid I, supporting product release testing, preventing accidental or fraudulent inclusion of prohibited aristolochic-acid-containing species, and providing forensic evidence for safety investigations.

Related standards and references

• Cites World Health Organization - Quality control methods for herbal materials (2011) for sampling guidance.
• Developed under ISO/TC 249 (Traditional Chinese medicine) and complemented by LC‑MS confirmation procedures (Annex B).

Keywords: ISO 23190:2021, aristolochic acid I, HPLC, Traditional Chinese medicine, herbal safety, DAD, LC‑MS, method validation, sample preparation.